The presence of herpes viral infection in prepartum women is an indication for caesarean section, as neonatal herpes may be acquired through the birth canal. Because failure to diagnose neonatal herpes or to treat the disease at an early stage can be fatal to the newborn child, it is extremely important to detect the presence of herpes virus infection immediately prior to a patient's giving birth. Since, at this point in time, the herpes virus remains a disorder of epidemic proportions, the occurrence of neonatal herpes is not at all infrequent.
It would thus be desirable to screen women prior to giving birth--i.e., at the time of admission to the hospital for labor and delivery--as well as during pregnancy. Screening immediately prior to delivery, however, has proved problematic. This is because the logistics of obtaining, culturing and testing a cervical cell specimen immediately prior to delivery do not, typically, allow for detection of the herpes virus in time to perform a caesarean section. The difficulty is in part due to the fact that present devices and methods of obtaining cervical cell specimens require a separate procedure which is in addition to the physician's or nurse's manual examination prior to delivery.
Most of the commercially available devices for obtaining cervical culture samples are "swabs", i.e., elongated rods having at one end a mound of absorbent cotton or other material for taking of the sample. For example, U.S. Pat. No. 3,386,549 to Barr et al. discloses a diagnostic swab having an elongated handle or stick and, at its distal end, a culture medium. Similarly, U.S. Pat. No. 3,626,470 to Antonides et al. describes a diagnostic device for obtaining cervical cell specimens which, at the distal end of an elongated handle, is provided with a sample collector of polysiloxane foam impregnated with a proteolytic enzyme. U.S. Pat. Nos. 3,586,380, 3,776,219 and 4,023,559 to Albeckoff, Brown and Gaskell, respectively, also show swab-like sampling devices for taking cervical cell samples.
A further drawback with present cervical culturing procedures is the time required for culturing and analysis of the cervical cells. While no method is presently available for expediting the analytical procedure, it is expected that upon development of monoclonal antibodies to herpes viral antigens, a rapid immunoassay, useful in conjunction with the present device and method, will be available.
Thus, the present invention addresses one of the aforementioned problems by providing a method for obtaining a cervical culture specimen that, as will be described, may be combined with a physician's manual examination prior to delivery. Alternatively, the nurses who typically perform the digital palpation of the cervix over the course of labor may also readily collect the sample without instrumentation.